DRKS00015782已完成2 期
Phase II prospective, randomized, double-blind clinical trial for the anti-inflammatory effects of an 8-week dose of Curazink (zinc histidine) in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease - DEZINK
Otto-von-Giericke University MagdeburgMedical Faculty0 个研究点目标入组 37 人开始时间: 2018年10月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 one（—）
- 性别
- All
入选标准
- •Patients with mild cognitive impairment and suspected Alzheimer's pathology according to NIA-AA criteria or patients with mild Alzheimer's dementia (MMST>= 18) according to NIA-AA criteria and in the presence of zinc deficiency or serum zinc concentrations in the lower normal range ( Zinc in the serum <=13 µmol / l, reference range: 9 - 18 µmol / l);
- •- Patients aged> 55 years;
- •- Patients or relatives must understand the goals of the study and the potential side effects;
- •- A willingness to consent must be given and a declaration of consent must be signed;
- •- Patients must have sufficient command of the German language in order to carry out the neuropsychological testing
排除标准
- •Patients with a different cause of dementia than Alzheimer's disease;
- •Patients with other severe neurological diseases (stroke, transient ischemic attack, brain tumor) in history;
- •- CRP concentrations in plasma> 20 mg / l
- •- Patients with a history of underlying infectious diseases with possible neurological manifestations (syphilis, borreliosis);
- •- Patients with a history of chronic liver disease (hepatitis B, C, autoimmune hepatitis);
- •- Patients with unstable heart disease;
- •- patients with severe kidney disease;
- •- Patients with insulin-dependent type 2 diabetes mellitus
- •- Patients with history of copper-bearing disease (Wilson's disease);
- •- patients with acute infections;
- •- Patients with known allergy to Curazink;
- •- taking medication / drug groups that interact with Curazink (tetracyclines, ofloxacin, other quinolones (ciprofloxacin, norfloxacin), D-penicillamine, DMPS ((RS) -2,3-disulfanylpropane-1-sulfonic acid), DMSA Dimercapto-succinic acid), EDTA (ethylenediamine tetraacetate), phosphates, iron, copper and calcium salts)
研究者
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